Module 14 2022

22/03/2022

EEA: Device content of an MAA

(provided in the new Quality guideline, effective 01 Jan 2022) • 3.2.P should contain information on the product-specific quality aspects related to the device component that may have an impact on the quality, safety and/or efficacy of the medicinal product. • 3.2.R should include relevant information related to the demonstration of compliance of the device(s) with MDR Annex 1 (the GSPRs) e.g. NBOp, NB Certificate of Conformity and/or device manufacturer’s EU Declaration of Conformity. • Module 3 should include appropriate information on the manufacture, control and usability of the DDC as defined for the intended patient population. • Usability and human factor studies are multidisciplinary in nature and could be included in section 5.3.5.4, ‘ Other Clinical Study Reports’ of the CTD, with appropriate reference to Module 3 as these may be reviewed by both pharmaceutical and clinical assessors, each with different focus. • For ATMPs , Article 117 does not apply in the case of combined ATMPs, however in the absence of specific guidance, the content of the MAA may be adapted, provided that this is justified under a risk- based approach.

Masterclass Lecture 8

The Organisation for Professionals in Regulatory Affairs

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Masterclass Lecture 8

The Organisation for Professionals in Regulatory Affairs

40

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